Cardiogenic ShockPhase 4CULPRIT-SHOCKNCT01927549

Culprit Lesion Only PCI Versus Multivessel PCI in Cardiogenic Shock

A Phase 4 study testing Immediate multivessel PCI and Culprit Lesion only PCI in people with Cardiogenic Shock and Acute Myocardial Infarction, run by University of Luebeck at 3 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The study compares the therapies of instant multivessel balloon angioplasty plus stent implantation or the balloon angioplasty plus stent implantation of the infarct artery alone with any possible graduated later treatment of the other vessels in patients with acute myocardial infarction with cardioganic shock. Read more about this study

Who is it for?: Ages 18 to 90 years
Conditions the study is for: Cardiogenic Shock, Acute Myocardial Infarction, Complications
What is being tested?: Immediate multivessel PCI and Culprit Lesion only PCI
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 706 participants
Where: 3 sitesGermany
Study dates: Apr 2013to Oct 2017
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Cardiogenic shock complicating acute myocardial infarction (STEMI or NSTEMI) with obligatory:
Planned early revascularization by PCI II) Multivessel coronary artery disease defined as more than 70% stenosis in at least 2 major vessels (more than 2 mm diameter) with identifiable culprit lesion III)
Systolic blood pressure less than 90 mmHg for more than 30 min or
catecholamines required to maintain pressure more than 90 mmHg during systole and IV) Signs of pulmonary congestion V) Signs of impaired organ perfusion with at least one of the following criteria
Altered mental status b) Cold, clammy skin and extremities c) Oliguria with urine output less than 30 ml/h d) Serum-lactate more than 2.0 mmol/l VI) Informed consent

Who cannot join

Resuscitation more than 30 minutes
No intrinsic heart action
Cerebral deficit with fixed dilated pupils (not drug-induced)
Need for primary urgent bypass surgery (to be determined after diagnostic angiography)
Single vessel disease
Mechanical cause of cardiogenic shock

Show all 13Show fewer

Onset of shock more than 12 h
Massive lung emboli
Age more than 90 years
Shock of other cause (bradycardia, sepsis, hypovolemia, etc.)
Other severe concomitant disease with limited life expectancy <6 months
Pregnancy
Known severe renal insufficiency (creatinine clearance <30 ml/kg)

Trial locations and contacts

3 sites in 1 country.

Germany3 sites

University of Goettingen
Göttingen
Heart Center Leipzig - University Hospital
Leipzig, 04289
University of Leipzig - Heart Center
Leipzig, 04289

Other trials in Germany

About this study

Official title: Prospective Randomized Multicenter Study Comparing Immediate Multivessel Revascularization by PCI Versus Culprit Lesion PCI With Staged Non-culprit Lesion Revascularization in Patients With Acute Myocardial Infarction Complicated by Cardiogenic Shock

The main study hypothesis is to explore if culprit vessel only PCI with potentially subsequent staged revascularization in comparison to immediate multivessel revascularization by PCI in patients with cardiogenic shock complicating acute myocardial infarction reduces the incidence of 30- day mortality and/or severe renal failure requiring renal replacement therapy.

Conditions: Cardiogenic Shock, Acute Myocardial Infarction, Complications
Being tested: Immediate multivessel PCI, Culprit Lesion only PCI
Keywords: cardiogenic shock, infarction, multivessel coronary artery disease, angioplasty
Medical subject headings: Shock, Cardiogenic, Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Immediate multivessel PCIProcedure or surgery
Culprit Lesion only PCIProcedure or surgery

Study groups in NCT01927549
Study group	Role	What they receive
Immediate multivessel PCI	Active comparator	After diagnostic angiography the culprit lesion is identified and PCI should be performed using standard techniques. The use of drug-eluting stents is recommended but not mandatory. All additional lesions in other major coronary arteries defined by a diameter >2 mm with high grade stenoses (>70% by visual assessment) should be intervened using standard techniques. Other major coronary arteries are defined by stenoses of other vessels and are not confined to a diagonal branch if the left anterior descending coronary artery was identified as the culprit lesion. Receives: Procedure: Immediate multivessel PCI
Culprit lesion only PCI	Active comparator	After diagnostic angiography the culprit lesion is identified and PCI of the culprit lesion should be performed using standard techniques. The use of drug-eluting stents is recommended but not mandatory. All other lesions should be left untreated in the acute setting. Complete revascularization of the non-culprit lesions may be performed at a later time point as staged procedure depending on remaining ischemia (as per guideline recommendations either by PCI or CABG). Receives: Procedure: Culprit Lesion only PCI

What is being measured

The primary outcome is the main question the study is designed to answer.

30-day mortality and/or severe renal failure requiring renal replacement therapy
Measured: 30 days

Secondary outcomes (19)

30-day mortality
Measured: 30 days
Requirement of renal replacement therapy
Measured: 30 days
Time to hemodynamic stabilization
Measured: 30 days
Duration of catecholamine therapy
Measured: 30 days
Serial creatinine-level creatinine-clearance
Measured: 30 days
Length of ICU-stay
Measured: 30 days
Serial intensive care scoring (SAPS-II score) until stabilization
Measured: 30 days
Requirement and length of mechanical ventilation
Measured: 30 days
All-cause death within 12 months follow-up
Measured: 12 months
Recurrent infarction within 30-days follow-up
Measured: 30 days
Death or recurrent infarction at 12 months follow-up
Measured: 12 months
Rehospitalization for congestive heart failure within 12 months follow-up
Measured: 12 months
Death/recurrent infarction/rehospitalization for congestive heart failure within 12 months
Measured: 12 months
Need for repeat revascularization (PCI and/or CABG) within 12 months follow-up
Measured: 12 months
Peak creatine kinase level during hospital stay
Measured: 30 days
Quality of life at 6 and 12 months assessed using Euroqol 5D (EQ-5D)
Measured: 12 months
Maximum creatine kinase-MB level
Measured: 30 days
Maximum troponin level
Measured: 30 days
Recurrent infarction within 12 months follow-up
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2013Oct 2017

First posted22 Aug 2013 (estimated)
Study startApr 2013
Primary completionJul 2017
Study completionOct 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (15)Papers the sponsor has linked to this study.
Other trials for Cardiogenic ShockStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 706 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01927549
Sponsor's protocol ID: CULPRIT-SHOCK1.2
Acronym: CULPRIT-SHOCK
Status last verified: Nov 2017
First submitted: 14 Aug 2013
Last updated: 9 Nov 2017
Results posted: No
Data monitoring committee: Yes

Publications

Jung C, Lang A, Duse DA, Bruno RR, Poss J, Wolff G, Ceglarek U, Zeymer U, Fuernau G, Zweck E, Desch S, Freund A, Isermann B, Pfeiler S, Wernly B, Kelm M, Thiele H, Gerdes N. Plasma Proteome Analysis Identifies Vascular Endothelial Growth Factor Receptor 1 as a Prognostic Biomarker in Cardiogenic Shock. Circ Heart Fail. 2025 Dec;18(12):e012890. doi: 10.1161/CIRCHEARTFAILURE.125.012890. Epub 2025 Oct 1.
PubMed 41031405
Zeymer-von Metnitz D, Ouarrak T, Huber K, Noc M, Desch S, Freund A, Zeymer U, Thiele H, Poss J. Mild induced hypothermia in patients with infarct-related cardiogenic shock and cardiac arrest: insights from the CULPRIT-SHOCK trial. Eur Heart J Acute Cardiovasc Care. 2026 Mar 10;15(1):15-23. doi: 10.1093/ehjacc/zuaf124.
PubMed 40986817
Zeymer U, Alushi B, Noc M, Mamas MA, Montalescot G, Fuernau G, Huber K, Poess J, de Waha-Thiele S, Schneider S, Ouarrak T, Desch S, Lauten A, Thiele H. Influence of Culprit Lesion Intervention on Outcomes in Infarct-Related Cardiogenic Shock With Cardiac Arrest. J Am Coll Cardiol. 2023 Mar 28;81(12):1165-1176. doi: 10.1016/j.jacc.2023.01.029.
PubMed 36948733
Bohme M, Desch S, Rosolowski M, Scholz M, Krohn K, Buttner P, Cross M, Kirchberg J, Rommel KP, Poss J, Freund A, Baber R, Isermann B, Ceglarek U, Metzeler KH, Platzbecker U, Thiele H. Impact of Clonal Hematopoiesis in Patients With Cardiogenic Shock Complicating Acute Myocardial Infarction. J Am Coll Cardiol. 2022 Oct 18;80(16):1545-1556. doi: 10.1016/j.jacc.2022.08.740.
PubMed 36229091
Ceglarek U, Schellong P, Rosolowski M, Scholz M, Willenberg A, Kratzsch J, Zeymer U, Fuernau G, de Waha-Thiele S, Buttner P, Jobs A, Freund A, Desch S, Feistritzer HJ, Isermann B, Thiery J, Poss J, Thiele H. The novel cystatin C, lactate, interleukin-6, and N-terminal pro-B-type natriuretic peptide (CLIP)-based mortality risk score in cardiogenic shock after acute myocardial infarction. Eur Heart J. 2021 Jun 21;42(24):2344-2352. doi: 10.1093/eurheartj/ehab110.
PubMed 33647946
Hauguel-Moreau M, Barthelemy O, Farhan S, Huber K, Rouanet S, Zeitouni M, Guedeney P, Hage G, Vicaut E, Zeymer U, Desch S, Thiele H, Montalescot G. Culprit lesion location and outcomes in patients with multivessel disease and infarct-related cardiogenic shock: a core laboratory analysis of the CULPRIT-SHOCK trial. EuroIntervention. 2021 Aug 6;17(5):e418-e424. doi: 10.4244/EIJ-D-20-00561.
PubMed 32894227
Sag CM, Zeymer U, Ouarrak T, Schneider S, Montalescot G, Huber K, Fuernau G, Freund A, Feistritzer HJ, Desch S, Thiele H, Maier LS. Effects of ON-Hours Versus OFF-Hours Admission on Outcome in Patients With Myocardial Infarction and Cardiogenic Shock: Results From the CULPRIT-SHOCK Trial. Circ Cardiovasc Interv. 2020 Sep;13(9):e009562. doi: 10.1161/CIRCINTERVENTIONS.120.009562. Epub 2020 Sep 4.
PubMed 32883104
Farhan S, Vogel B, Montalescot G, Barthelemy O, Zeymer U, Desch S, de Waha-Thiele S, Maier LS, Sandri M, Akin I, Fuernau G, Ouarrak T, Hauguel-Moreau M, Schneider S, Thiele H, Huber K. Association of Culprit Lesion Location With Outcomes of Culprit-Lesion-Only vs Immediate Multivessel Percutaneous Coronary Intervention in Cardiogenic Shock: A Post Hoc Analysis of a Randomized Clinical Trial. JAMA Cardiol. 2020 Dec 1;5(12):1329-1337. doi: 10.1001/jamacardio.2020.3377.
PubMed 32845312
Rubini Gimenez M, Zeymer U, Desch S, de Waha-Thiele S, Ouarrak T, Poess J, Meyer-Saraei R, Schneider S, Fuernau G, Stepinska J, Huber K, Windecker S, Montalescot G, Savonitto S, Jeger RV, Thiele H. Sex-Specific Management in Patients With Acute Myocardial Infarction and Cardiogenic Shock: A Substudy of the CULPRIT-SHOCK Trial. Circ Cardiovasc Interv. 2020 Mar;13(3):e008537. doi: 10.1161/CIRCINTERVENTIONS.119.008537. Epub 2020 Mar 10.
PubMed 32151161
Feistritzer HJ, Desch S, Zeymer U, Fuernau G, de Waha-Thiele S, Dudek D, Huber K, Stepinska J, Schneider S, Ouarrak T, Thiele H. Prognostic Impact of Atrial Fibrillation in Acute Myocardial Infarction and Cardiogenic Shock. Circ Cardiovasc Interv. 2019 Jun;12(6):e007661. doi: 10.1161/CIRCINTERVENTIONS.118.007661. Epub 2019 Jun 6.
PubMed 31167601
Thiele H, Akin I, Sandri M, de Waha-Thiele S, Meyer-Saraei R, Fuernau G, Eitel I, Nordbeck P, Geisler T, Landmesser U, Skurk C, Fach A, Jobs A, Lapp H, Piek JJ, Noc M, Goslar T, Felix SB, Maier LS, Stepinska J, Oldroyd K, Serpytis P, Montalescot G, Barthelemy O, Huber K, Windecker S, Hunziker L, Savonitto S, Torremante P, Vrints C, Schneider S, Zeymer U, Desch S; CULPRIT-SHOCK Investigators. One-Year Outcomes after PCI Strategies in Cardiogenic Shock. N Engl J Med. 2018 Nov 1;379(18):1699-1710. doi: 10.1056/NEJMoa1808788. Epub 2018 Aug 25.
PubMed 30145971
Thiele H, Akin I, Sandri M, Fuernau G, de Waha S, Meyer-Saraei R, Nordbeck P, Geisler T, Landmesser U, Skurk C, Fach A, Lapp H, Piek JJ, Noc M, Goslar T, Felix SB, Maier LS, Stepinska J, Oldroyd K, Serpytis P, Montalescot G, Barthelemy O, Huber K, Windecker S, Savonitto S, Torremante P, Vrints C, Schneider S, Desch S, Zeymer U; CULPRIT-SHOCK Investigators. PCI Strategies in Patients with Acute Myocardial Infarction and Cardiogenic Shock. N Engl J Med. 2017 Dec 21;377(25):2419-2432. doi: 10.1056/NEJMoa1710261. Epub 2017 Oct 30.
PubMed 29083953
Quayyum Z, Briggs A, Robles-Zurita J, Oldroyd K, Zeymer U, Desch S, Waha S, Thiele H. Protocol for an economic evaluation of the randomised controlled trial of culprit lesion only PCI versus immediate multivessel PCI in acute myocardial infarction complicated by cardiogenic shock: CULPRIT-SHOCK trial. BMJ Open. 2017 Aug 18;7(8):e014849. doi: 10.1136/bmjopen-2016-014849.
PubMed 28821512
Thiele H, Desch S, Piek JJ, Stepinska J, Oldroyd K, Serpytis P, Montalescot G, Noc M, Huber K, Fuernau G, de Waha S, Meyer-Saraei R, Schneider S, Windecker S, Savonitto S, Briggs A, Torremante P, Vrints C, Schuler G, Ceglarek U, Thiery J, Zeymer U; CULPRIT-SHOCK Investigators. Multivessel versus culprit lesion only percutaneous revascularization plus potential staged revascularization in patients with acute myocardial infarction complicated by cardiogenic shock: Design and rationale of CULPRIT-SHOCK trial. Am Heart J. 2016 Feb;172:160-9. doi: 10.1016/j.ahj.2015.11.006. Epub 2015 Dec 1.
PubMed 26856228
AbouEzzeddine OF, Lala A, Khazanie PP, Shah R, Ho JE, Chen HH, Pang PS, McNulty SE, Anstrom KJ, Hernandez AF, Redfield MM; NHLBI Heart Failure Clinical Research Network. Evaluation of a provocative dyspnea severity score in acute heart failure. Am Heart J. 2016 Feb;172:34-41. doi: 10.1016/j.ahj.2015.10.009. Epub 2015 Oct 20.
PubMed 26856213

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 9 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective Randomized Multicenter Study Comparing Immediate Multivessel Revascularization by PCI Versus Culprit Lesion PCI With Staged Non-culprit Lesion Revascularization in Patients With Acute Myocardial Infarction Complicated by Cardiogenic Shock
ClinicalTrials.gov ID: NCT01927549
Acronym / sponsor ID: CULPRIT-SHOCK / CULPRIT-SHOCK1.2
Conditions: Cardiogenic Shock, Acute Myocardial Infarction, Complications
Keywords: cardiogenic shock, infarction, multivessel coronary artery disease, angioplasty
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 706 participants (actual)
Lead sponsor: University of LuebeckUniversity, hospital or other
Collaborators: European Commission, German Cardiac Society, Deutsche Stiftung für Herzforschung, Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
Study start: Apr 2013
Primary completion: Jul 2017 (actual)
Study completion: Oct 2017 (actual)
First posted: 22 Aug 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Immediate multivessel PCI	Active comparator	Procedure: Immediate multivessel PCIAfter diagnostic angiography the culprit lesion is identified and PCI should be performed using standard techniques. The use of drug-eluting stents is recommended but not mandatory. All additional lesions in other major coronary arteries defined by a diameter >2 mm with high grade stenoses (>70% by visual assessment) should be intervened using standard techniques. Other major coronary arteries are defined by stenoses of other vessels and are not confined to a diagonal branch if the left anterior descending coronary artery was identified as the culprit lesion.
Culprit lesion only PCI	Active comparator	Procedure: Culprit Lesion only PCIAfter diagnostic angiography the culprit lesion is identified and PCI of the culprit lesion should be performed using standard techniques. The use of drug-eluting stents is recommended but not mandatory. All other lesions should be left untreated in the acute setting. Complete revascularization of the non-culprit lesions may be performed at a later time point as staged procedure depending on remaining ischemia (as per guideline recommendations either by PCI or CABG).

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Cardiogenic shock complicating acute myocardial infarction (STEMI or NSTEMI) with obligatory:
Planned early revascularization by PCI II) Multivessel coronary artery disease defined as more than 70% stenosis in at least 2 major vessels (more than 2 mm diameter) with identifiable culprit lesion III)
Systolic blood pressure less than 90 mmHg for more than 30 min or
catecholamines required to maintain pressure more than 90 mmHg during systole and IV) Signs of pulmonary congestion V) Signs of impaired organ perfusion with at least one of the following criteria
Altered mental status b) Cold, clammy skin and extremities c) Oliguria with urine output less than 30 ml/h d) Serum-lactate more than 2.0 mmol/l VI) Informed consent

Key exclusion criteria (13 listed)

Resuscitation more than 30 minutes
No intrinsic heart action
Cerebral deficit with fixed dilated pupils (not drug-induced)
Need for primary urgent bypass surgery (to be determined after diagnostic angiography)
Single vessel disease

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Immediate multivessel PCI	Procedure or surgery	Immediate multivessel PCI
Culprit Lesion only PCI	Procedure or surgery	Culprit lesion only PCI

Primary outcome

30-day mortality and/or severe renal failure requiring renal replacement therapy
Time frame: 30 days

19 secondary outcomes

30-day mortality
Time frame: 30 days
Requirement of renal replacement therapy
Time frame: 30 days
Time to hemodynamic stabilization
Time frame: 30 days
Duration of catecholamine therapy
Time frame: 30 days
Serial creatinine-level creatinine-clearance
Time frame: 30 days
Length of ICU-stay
Time frame: 30 days
Serial intensive care scoring (SAPS-II score) until stabilization
Time frame: 30 days
Requirement and length of mechanical ventilation
Time frame: 30 days
All-cause death within 12 months follow-up
Time frame: 12 months
Recurrent infarction within 30-days follow-up
Time frame: 30 days
Death or recurrent infarction at 12 months follow-up
Time frame: 12 months
Rehospitalization for congestive heart failure within 12 months follow-up
Time frame: 12 months
Death/recurrent infarction/rehospitalization for congestive heart failure within 12 months
Time frame: 12 months
Need for repeat revascularization (PCI and/or CABG) within 12 months follow-up
Time frame: 12 months
Peak creatine kinase level during hospital stay
Time frame: 30 days
Quality of life at 6 and 12 months assessed using Euroqol 5D (EQ-5D)
Time frame: 12 months
Maximum creatine kinase-MB level
Time frame: 30 days
Maximum troponin level
Time frame: 30 days
Recurrent infarction within 12 months follow-up
Time frame: 12 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2017.
Derived from this study: PubMed 41031405Jung C, Lang A, Duse DA, Bruno RR, Poss J, Wolff G, Ceglarek U, Zeymer U, Fuernau G, Zweck E, Desch S, Freund A, Isermann B, Pfeiler S, Wernly B, Kelm M, Thiele H, Gerdes N. Plasma Proteome Analysis Identifies Vascular Endothelial Growth Factor Receptor 1 as a Prognostic Biomarker in Cardiogenic Shock. Circ Heart Fail. 2025 Dec;18(12):e012890. doi: 10.1161/CIRCHEARTFAILURE.125.012890. Epub 2025 Oct 1.
Derived from this study: PubMed 40986817Zeymer-von Metnitz D, Ouarrak T, Huber K, Noc M, Desch S, Freund A, Zeymer U, Thiele H, Poss J. Mild induced hypothermia in patients with infarct-related cardiogenic shock and cardiac arrest: insights from the CULPRIT-SHOCK trial. Eur Heart J Acute Cardiovasc Care. 2026 Mar 10;15(1):15-23. doi: 10.1093/ehjacc/zuaf124.
Derived from this study: PubMed 36948733Zeymer U, Alushi B, Noc M, Mamas MA, Montalescot G, Fuernau G, Huber K, Poess J, de Waha-Thiele S, Schneider S, Ouarrak T, Desch S, Lauten A, Thiele H. Influence of Culprit Lesion Intervention on Outcomes in Infarct-Related Cardiogenic Shock With Cardiac Arrest. J Am Coll Cardiol. 2023 Mar 28;81(12):1165-1176. doi: 10.1016/j.jacc.2023.01.029.
Derived from this study: PubMed 36229091Bohme M, Desch S, Rosolowski M, Scholz M, Krohn K, Buttner P, Cross M, Kirchberg J, Rommel KP, Poss J, Freund A, Baber R, Isermann B, Ceglarek U, Metzeler KH, Platzbecker U, Thiele H. Impact of Clonal Hematopoiesis in Patients With Cardiogenic Shock Complicating Acute Myocardial Infarction. J Am Coll Cardiol. 2022 Oct 18;80(16):1545-1556. doi: 10.1016/j.jacc.2022.08.740.
Derived from this study: PubMed 33647946Ceglarek U, Schellong P, Rosolowski M, Scholz M, Willenberg A, Kratzsch J, Zeymer U, Fuernau G, de Waha-Thiele S, Buttner P, Jobs A, Freund A, Desch S, Feistritzer HJ, Isermann B, Thiery J, Poss J, Thiele H. The novel cystatin C, lactate, interleukin-6, and N-terminal pro-B-type natriuretic peptide (CLIP)-based mortality risk score in cardiogenic shock after acute myocardial infarction. Eur Heart J. 2021 Jun 21;42(24):2344-2352. doi: 10.1093/eurheartj/ehab110.
Derived from this study: PubMed 32894227Hauguel-Moreau M, Barthelemy O, Farhan S, Huber K, Rouanet S, Zeitouni M, Guedeney P, Hage G, Vicaut E, Zeymer U, Desch S, Thiele H, Montalescot G. Culprit lesion location and outcomes in patients with multivessel disease and infarct-related cardiogenic shock: a core laboratory analysis of the CULPRIT-SHOCK trial. EuroIntervention. 2021 Aug 6;17(5):e418-e424. doi: 10.4244/EIJ-D-20-00561.
Derived from this study: PubMed 32883104Sag CM, Zeymer U, Ouarrak T, Schneider S, Montalescot G, Huber K, Fuernau G, Freund A, Feistritzer HJ, Desch S, Thiele H, Maier LS. Effects of ON-Hours Versus OFF-Hours Admission on Outcome in Patients With Myocardial Infarction and Cardiogenic Shock: Results From the CULPRIT-SHOCK Trial. Circ Cardiovasc Interv. 2020 Sep;13(9):e009562. doi: 10.1161/CIRCINTERVENTIONS.120.009562. Epub 2020 Sep 4.
Derived from this study: PubMed 32845312Farhan S, Vogel B, Montalescot G, Barthelemy O, Zeymer U, Desch S, de Waha-Thiele S, Maier LS, Sandri M, Akin I, Fuernau G, Ouarrak T, Hauguel-Moreau M, Schneider S, Thiele H, Huber K. Association of Culprit Lesion Location With Outcomes of Culprit-Lesion-Only vs Immediate Multivessel Percutaneous Coronary Intervention in Cardiogenic Shock: A Post Hoc Analysis of a Randomized Clinical Trial. JAMA Cardiol. 2020 Dec 1;5(12):1329-1337. doi: 10.1001/jamacardio.2020.3377.
Derived from this study: PubMed 32151161Rubini Gimenez M, Zeymer U, Desch S, de Waha-Thiele S, Ouarrak T, Poess J, Meyer-Saraei R, Schneider S, Fuernau G, Stepinska J, Huber K, Windecker S, Montalescot G, Savonitto S, Jeger RV, Thiele H. Sex-Specific Management in Patients With Acute Myocardial Infarction and Cardiogenic Shock: A Substudy of the CULPRIT-SHOCK Trial. Circ Cardiovasc Interv. 2020 Mar;13(3):e008537. doi: 10.1161/CIRCINTERVENTIONS.119.008537. Epub 2020 Mar 10.
Derived from this study: PubMed 31167601Feistritzer HJ, Desch S, Zeymer U, Fuernau G, de Waha-Thiele S, Dudek D, Huber K, Stepinska J, Schneider S, Ouarrak T, Thiele H. Prognostic Impact of Atrial Fibrillation in Acute Myocardial Infarction and Cardiogenic Shock. Circ Cardiovasc Interv. 2019 Jun;12(6):e007661. doi: 10.1161/CIRCINTERVENTIONS.118.007661. Epub 2019 Jun 6.
Derived from this study: PubMed 30145971Thiele H, Akin I, Sandri M, de Waha-Thiele S, Meyer-Saraei R, Fuernau G, Eitel I, Nordbeck P, Geisler T, Landmesser U, Skurk C, Fach A, Jobs A, Lapp H, Piek JJ, Noc M, Goslar T, Felix SB, Maier LS, Stepinska J, Oldroyd K, Serpytis P, Montalescot G, Barthelemy O, Huber K, Windecker S, Hunziker L, Savonitto S, Torremante P, Vrints C, Schneider S, Zeymer U, Desch S; CULPRIT-SHOCK Investigators. One-Year Outcomes after PCI Strategies in Cardiogenic Shock. N Engl J Med. 2018 Nov 1;379(18):1699-1710. doi: 10.1056/NEJMoa1808788. Epub 2018 Aug 25.
Derived from this study: PubMed 29083953Thiele H, Akin I, Sandri M, Fuernau G, de Waha S, Meyer-Saraei R, Nordbeck P, Geisler T, Landmesser U, Skurk C, Fach A, Lapp H, Piek JJ, Noc M, Goslar T, Felix SB, Maier LS, Stepinska J, Oldroyd K, Serpytis P, Montalescot G, Barthelemy O, Huber K, Windecker S, Savonitto S, Torremante P, Vrints C, Schneider S, Desch S, Zeymer U; CULPRIT-SHOCK Investigators. PCI Strategies in Patients with Acute Myocardial Infarction and Cardiogenic Shock. N Engl J Med. 2017 Dec 21;377(25):2419-2432. doi: 10.1056/NEJMoa1710261. Epub 2017 Oct 30.

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RecruitingObservational study
Evaluation of Acid-base Disorders and Ventilation Settings in Cardiogenic Shock and Post-cardiac Arrest Patients: Comparison With VentilO Algorithm
Cardiac Arrest (CA), Cardiogenic Shock
Not yet recruitingObservational study
Hemodynamic Evaluation of Left Atrial Pressure in Relationship to Pulmonary Capillary Wedge Pressure in Cardio Thoracic Patients
Cardiogenic Shock, Pulmonary Edema Cardiac Cause
Not yet recruitingPhase 4
Capital Offload-Shock
Hypervolemia, Cardiogenic Shock
Recruiting
CRP Apheresis in Infarct-Related Cardiogenic Shock
Cardiogenic Shock, Acute Myocardial Infarction (AMI)
RecruitingObservational study
Cardiogenic Shock Working Group Registry
Cardiogenic Shock

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Holger Thiele, MD study chair

Heart Center Leipzig - University Hospital

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Immediate multivessel PCI and Culprit Lesion only PCI in people with Cardiogenic Shock and Acute Myocardial Infarction, run by University of Luebeck at 3 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

30-day mortality and/or severe renal failure requiring renal replacement therapy (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01927549, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2017.